A conservative watchdog group, Judicial Watch, has recently published new government data of adverse events (AEs) related to Gardasil, Merck & Co.'s vaccine against human papillomavirus (HPV). The Food and Drug Administration (FDA) maintains data on AEs reported by US physicians. CDC helps FDA monitor AEs.
Of the 2 million to 3 million Gardasil vaccinations US women may have received to date, most of the 1,637 reported AEs have been minor - such as injection site pain, itching, and dizziness. The proportion of AEs is not considered high. FDA deemed 136 AEs serious, including seizures, and paralysis-inducing Guillain-Barre Syndrome.
Two females died of blood clots after receiving Gardasil, but they were also taking birth control, a known risk factor for blood clots. Also in the AE data was a 12-year-old with a history of heart disease who died of flu-related heart inflammation, said CDC. Of 18 pregnant women with reported AEs, 16 miscarried, one was diagnosed with an abnormal fetus, and the outcome was not reported for another diagnosed at high risk for fetal defect.
Gardasil's label states it is "not recommended for use in pregnant women," since its use among this population has not been well-studied, said Dr. Richard Haupt, Merck's executive director of medical affairs. At least some of the pregnant women with pregnancy-related AEs were unaware they were pregnant.
After five birth defects were reported during Gardasil's clinical trials, Merck promised FDA it would compile a registry of pregnant women exposed to the vaccine and any potential effect on pregnancy. Of more than 300 entries, Merck said its registry had received no reports of congenital abnormality.
An FDA spokesperson, Karen Riley, said the agency is monitoring AEs closely, but "we haven't seen anything at this point that would suggest we'd make any changes in the product," including with respect to pregnancy. Judicial Watch is opposed to legislative measures that would require HPV vaccinations for pre-teen schoolgirls.
Wall Street Journal (05.24.07):: John Carreyrou
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